Arthrex® AR-9120-03Recalls & reported problems
Arthrex, Inc. · UNIVERSAL GLENOID - BASEPLATE LARGE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867057364), received between May 9, 2022 and Jul 26, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem2
- Biocompatibility1
- Degraded1
Patient problems
- Failure of Implant1
- Metal Related Pathology1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A METALLOSIS. THE IMPLANT WAS IMPLANTED FOUR YEARS AGO WITH BONE GRAFT AUGMENTATION. NO FURTHER INFORMATION WAS PROVIDED. UPDATE 12-JUL-2024: FURTHER INFORMATION WERE PROVIDED THAT DURING AN INITIAL SURGERY ON (B)(6) 2020 THE FOLLOWING DEVICES WERE IMPLANTED DUE TO AN OMARTHROSIS WITH B2 GLENOID SITUATION WITH A RETRO OF JUST UNDER 30 DEGREES. AR-9120-03, AR-9165-25NL, AR-9145-36, AR-9121-03, AR-9300-45CPC, AR-9301-04. ON (B)(6) 2024 THE REVISION SURGERY WAS PERFORMED. AS PART OF THE REVISION THE ECLIPSE AND UNIVERSAL GLENOID WERE ALL REMOVED DUE TO A SEVERE METALLOSIS. THE SURGEON DECIDED TO FIRST BUILD UP THE GLENOID WITH ALLOGRAFT IN A TWO-SIDED PROCEDURE AND TO INSERT A CEMENT SPACER ON THE HUMERUS SIDE. IN THE SECOND STEP - A UNIVERS REVERSE WILL BE INSERTED IN AUTUMN WITH PLANNING.
Patient problems: Metal Related Pathology
MAUDE report 19837316 ↗InjuryOct 20, 2023Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2023 THE PATIENT DEVELOPED A SEVERE INFECTION WHICH AFFECTED THE PATIENT FOR 6 MONTHS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE INVOLVED IMPLANTS. . NO FURTHER INFORMATION RECEIVED.
Patient problems: Unspecified Infection
MAUDE report 17976719 ↗InjuryMay 9, 2022Degraded
IT WAS REPORTED THAT ONE YEAR AFTER THE IMPLANTATION OF A RIGHT SHOULDER TOTAL ENDO-PROSTHESIS ECLIPSE ON (B)(6) 2016, POLYETHYLENE DEGRADATION WAS IDENTIFIED POST-OPERATIVELY. THIS RESULTED IN A BONE DEFECT WHICH LED TO A REVISION SURGERY TO CHANGE THE IMPLANT TO AN INVERSE PROSTHESIS.
Patient problems: Failure of Implant
MAUDE report 14337024 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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